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news.Eli Lilly and Company and Boehringer Ingelheim have received marketing authorization from the European Commission (EC) for their insulin glargine product to treat diabetes in adults, adolescents and children aged two years and above.
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The insulin glargine product is the first insulin treatment approved through the European Medicines Agency’s (EMA’s) biosimilar pathway and the fourth diabetes product approved in the European Union (EU) from the Lilly-Boehringer Ingelheim alliance.
In June, the product received a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP).
Lilly Diabetes president Enrique Conterno said the marketing authorization for this insulin glargine product in Europe is a significant achievement for the Lilly-Boehringer Ingelheim alliance.
"We believe that insulin glargine will continue to be widely used for many years, and Lilly and Boehringer Ingelheim are committed to addressing the needs of people living with diabetes and providing support beyond the medicine," Conterno said.
The alliance’s insulin glargine product is intended to provide long-lasting blood sugar control between meals and at night, and will be available in a pre-filled pen and cartridges for a reusable pen.
The product is a basal insulin with the same amino acid sequence as Lantus (insulin glargine), which is marketed by Sanofi.
Boehringer Ingelheim chief medical officer Dr Klaus Dugi said: "Basal insulin is an important mainstay of treatment for people with type 1 and type 2 diabetes, and we’re pleased that Lilly/Boehringer Ingelheim’s insulin glargine product will provide healthcare professionals and patients with another option to meet their insulin treatment needs, along with significant expertise and support from the Lilly-Boehringer Ingelheim Alliance."
The European approval for the insulin glargine product is based upon a comprehensive clinical data program, which showed it has similar efficacy and safety compared to the currently marketed insulin glargine product in people with type 1 and type 2 diabetes.
Image: Lilly and Boehringer’s insulin glargine product will be available in a pre-filled pen and cartridges for a reusable pen. Photo: courtesy of BruceBlaus.